Lantus Versus NPH: Comparison in Insulin Naive People Not Adequately Controlled With at Least One Oral Anti Diabetics (OAD) Treatment (LANCELOT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00949442
Recruitment Status : Completed
First Posted : July 30, 2009
Last Update Posted : August 21, 2012
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Brief Summary:

Primary Objective:

To demonstrate the superiority of insulin glargine over insulin NPH (Neutral Protamin Hagedornon) the change in HbA1c from baseline to the end of the treatment period.

Secondary Objective:

To compare between treatment groups:

  • Plasma glucose (fasting, nocturnal) over time,
  • Changes from baseline in HbA1c over time,
  • Percentage of patients who reach the target of HbA1c <7 and <6.5,
  • Use of prandial insulin as rescue medication at month 6,
  • Incidence and rate of hypoglycemia (symptomatic diurnal and nocturnal, asymptomatic and severe),
  • Daily dose of insulin,
  • Change in body weight from baseline,
  • Evolution of 8-point plasma-glucose (PG) profiles,
  • Overall safety,
  • Patient reported outcomes (treatment satisfaction).

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Glargine (HOE901) [Lantus] Drug: Glimepiride Drug: human insulin [NPH] Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 708 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Superiority of Insulin Glargine Lantus vs. NPH: Treat to Normoglycemia Concept.Effect of Insulin Glargine in Comparison to Insulin NPH in Insulin-nave People With Type 2 Diabetes Mellitus Treated With at Least One OAD and Not Adequately Controlled
Study Start Date : July 2009
Actual Primary Completion Date : July 2012
Actual Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1

Before randomization (common with arm 2):

2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride

After randomization:

36 weeks of study treatment phase: Insulin Glargine + OAD(s) at stable dose

Drug: Insulin Glargine (HOE901) [Lantus]
100 Units/ml solution for injection in a pre-filled pen SoloStar® (3 ml)
Drug: Glimepiride
tablets of 1 and 2 mg
Active Comparator: 2

Before randomization (common with arm 1):

2 weeks of Screening phase: Oral Anti Diabetics (OAD) 2 weeks of Run-In phase: switch of OAD (Sulfonylurea (except Glimepiride), glinides or alpha-glucosidase inhibitor) to Glimepiride

After randomization:

36 weeks of study treatment phase: NPH + OAD(s) at stable dose

Drug: Glimepiride
tablets of 1 and 2 mg
Drug: human insulin [NPH]
100 IU/ml suspension for injection in a prefilled pen OptiSet® (3 ml)

Primary Outcome Measures :
  1. HbA1c [ Time Frame: Recorded at baseline (week 0), week 12, week 24 and week 36 ]

Secondary Outcome Measures :
  1. Self-monitored fasting plasma glucose (FPG) [ Time Frame: Before baseline (week 0), weeks 12, 24 and 36 ]
  2. 8-points profiles [ Time Frame: The week before baseline, at 12, 24 and 36 weeks ]
  3. Episodes of hypoglycemia [ Time Frame: From the week -2 to the week 36 ]
  4. Daily doses of insulin [ Time Frame: At week 1, week 2, week 3, week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 20, week 24, week 28, week 32, week 36 ]
  5. Need of additional prandial insulin [ Time Frame: At week 24 ]

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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria

  • Insulin-naïve type 2 diabetes mellitus
  • Type 2 diabetes mellitus diagnosed for at least 1 year
  • Treated with at least one OAD (Metformin [daily dose of at least 1000mg], Sulfonylurea, glinides or alpha-glucosidase inhibitor) at stable dose for at least 3 months.
  • HbA1c > or = 7.0% and < or = 10.5%
  • BMI < 40 kg/m²
  • Ability and willingness to perform plasma glucose monitoring using the sponsor-provided glucose meter and patient diary at home
  • Informed consent obtained in writing at enrolment into the study
  • Willingness and ability to comply with the study protocol

Exclusion criteria:

  • Treatment with GLP-1 agonists or with DPP-IV inhibitors in the 3 months prior to study entry
  • Treatment with TZD as monotherapy
  • Diabetes mellitus other than Type 2 (e.g. secondary to pancreatic disorders, drugs or chemical agents intake...)
  • Active proliferative retinopathy, as defined by a photocoagulation or vitrectomy occurrence in the 6 months prior to visit 1, or any other unstable (rapidly progressing) retinopathy that may require photocoagulation or surgical treatment during the study (an optic fundus examination should have been performed within the 2 years prior to study entry)
  • Impaired renal function: serum creatinine > or =1.5 mg/dL (> or = 133µmol/L) or > or = 1.4 mg/dL (> or = 124 µmol/L) in men and women, respectively
  • History of sensitivity to the study drugs or to drugs with a similar chemical structure
  • Impaired hepatic function (ALT and/or AST > 3 x upper limit of normal range)
  • Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method),
  • Treatment with systemic corticosteroids within the 3 months prior to study entry or likelihood of requiring treatments during the study which are not permitted.
  • Treatment with an investigational product in the 30 days prior to visit 1
  • Alcohol or drug abuse in the last year
  • Presence of any condition (medical, psychological, social or geographical), current or anticipated that the Investigator feels would compromise the patient's safety or limit the patient successful participation in the study (including night shift worker)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00949442

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Sponsors and Collaborators
Study Director: Valerie Pilorget, MD Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sanofi Identifier: NCT00949442     History of Changes
Other Study ID Numbers: LANTU_C_02762
EUDRACT #: 2007-006640-22
First Posted: July 30, 2009    Key Record Dates
Last Update Posted: August 21, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin Glargine
Hypoglycemic Agents
Glycoside Hydrolase Inhibitors
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action